Methods for the treatment of cancer and benign lesions by ablation
Inventors
Morhard, Robert • Ramanujam, Nirmala • Katz, David
Assignees
Publication Number
US-12350341-B2
Publication Date
2025-07-08
Expiration Date
2038-03-02
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Abstract
The present disclosure provides methods for the treatment of a lesion, such as a cancerous lesion, a precancerous lesion, or a benign lesion (e.g. a benign lesion on the skin) in a subject comprising administering to the subject a therapeutically effective amount of a therapy solution comprising a viscous carrier and an alcohol or hydrophobic anti-cancer agent, such that the lesion is treated. In some embodiments, the therapy solution includes an ethyl cellulose-ethanol mixture. In some embodiments, the therapy solution is administered to the lesion at a rate of from about 1 mL/hr to about 15 mL/hr.
Core Innovation
The invention provides methods for treating lesions, including cancerous, precancerous, and benign lesions, by administering to the subject a therapeutically effective amount of a therapy solution comprising a viscous carrier and an alcohol or hydrophobic anti-cancer agent, such as an ethyl cellulose-ethanol mixture. The therapy solution is administered at controlled rates, typically from about 1 mL/hr to about 15 mL/hr, to effectively treat the lesion. Ethyl cellulose is soluble in ethanol and forms a stiff gel when exposed to the aqueous tissue environment, enhancing localization and therapeutic efficacy.
The background problem addressed by this invention is the limited access to adequate and effective treatments for malignant, premalignant, and benign lesions worldwide due to physiological constraints, lack of resources, and insufficient healthcare infrastructure. Current ethanol ablation techniques for tumors are limited by leakage into surrounding tissue and rapid vascular clearance, especially in non-capsulated tumors such as epithelial tumors. There is a need for a low-cost, easily administered, and more efficacious treatment that does not require specialized equipment and can overcome these limitations.
This invention solves these problems by developing a therapy solution with increased viscosity via ethyl cellulose, which forms a gel in situ, controlling the distribution and retention of the ablative agent within the lesion. By optimizing the injection rate and ethyl cellulose concentration, the treatment achieves improved tumor volume reduction and complete lesion regression, as demonstrated in preclinical models of squamous cell carcinoma. Additionally, the inclusion of clinically approved fluorescent dyes enables real-time visualization of therapy distribution, further enhancing treatment precision.
Claims Coverage
The patent contains one independent claim focused on a method of treating lesions using a specific therapy solution, with additional claims detailing various features and embodiments of that method.
Viscous carrier comprising ethyl cellulose at specified concentration
The therapy solution comprises a viscous carrier which includes ethyl cellulose, wherein the concentration of ethyl cellulose is at least 3% by weight and extends up to about 10% by weight as specified in various embodiments.
Administration of therapy solution at controlled infusion rates
The therapy solution is administered to the lesion at a controlled injection rate ranging from about 1 mL/hr to about 15 mL/hr to optimize therapeutic efficacy.
Therapy solution comprising an alcohol or hydrophobic agent
The therapy solution includes an alcohol such as ethanol or a hydrophobic anti-cancer agent, which may be a chemotherapeutic or photosensitizer, to treat the lesion.
Direct injection or infusion into lesion at one or more sites
The therapy solution is administered by direct injection or infusion into the lesion at one or more sites to ensure localized treatment.
Use of a detectable compound for imaging distribution
The therapy solution may further comprise a detectable compound, including fluorescent agents like fluorescein or indocyanine green, facilitating in vivo real-time imaging of distribution during and after administration.
The independent claim and its dependent claims cover a method of treating lesions by intralesional administration of a viscous therapy solution comprising ethyl cellulose at specified concentrations combined with alcohol or hydrophobic agents, delivered at controlled rates to improve treatment efficacy and facilitate real-time visualization.
Stated Advantages
The method is ultra-low cost, requiring no specialized equipment, making it accessible in resource-limited settings.
Enhanced therapeutic efficacy through improved localization and retention of the ablative agent within the lesion due to the gel-forming viscous carrier.
Injection rate optimization reduces leakage and improves distribution volume leading to better treatment outcomes.
The inclusion of a detectable compound allows for in vivo, real-time, non-invasive visualization of treatment distribution to monitor and adjust therapy.
The method effectively treats non-capsulated tumors and other lesions where traditional ethanol ablation is less effective.
Reduced injection volumes relative to tumor volume help minimize unintended side effects.
Documented Applications
Treatment of cancerous lesions including a range of carcinomas, lymphomas, blastomas, sarcomas, and specific cancers such as breast, prostate, colon, squamous cell, lung, ovarian, cervical, gastrointestinal, pancreatic, liver, bladder, kidney, skin, melanoma, myeloma, head and neck cancers, and Ewing sarcoma.
Treatment of precancerous lesions such as those in the cervix, head and neck, and skin.
Treatment of benign lesions including benign epithelial lesions such as warts and skin tags.
Ablation of non-capsulated solid tumors and epithelial tumors along body lumens.
Visualization of injected therapy distribution in vivo using fluorescent imaging for real-time procedural guidance.
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